{"description":"Documents matching 'must include single patient electronic'","count":4923,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=must+include+single+patient+electronic&format=json&page=2","results":[{"title":"Announcement of Requirements and Registration for “EHIgnite Challenge”","type":"Notice","abstract":"The EHIgnite Challenge addresses data usability challenges in single patient electronic health information (EHI) exports. This challenge seeks to incentivize the development of tools, platforms, and workflows that transform single patient EHI exports into usable, readable, and actionable information that supports clinical care, patient engagement, and informed decision-making.","document_number":"2026-10068","html_url":"https://www.federalregister.gov/documents/2026/05/20/2026-10068/announcement-of-requirements-and-registration-for-ehignite-challenge","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-20/pdf/2026-10068.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10068.pdf?1779117307","publication_date":"2026-05-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"transmitted electronically and would be included in a designated record set, but excludes psychotherapy notes and certain other information as specified in regulation. Health IT developers of certified Health IT are required to support two use cases as set forth in 45 CFR 170.315(b)(10): \n \n Single Patient EHI Export: \n \n —Export EHI for a single patient at any time the user (or user's representative) chooses without Developer assistance \n —The export must be created in a timely fashion \n —Must include all EHI for a single patient \n —Must be electronic"},{"title":"Patient-Matched Guides for Orthopedic Implants; Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled \"Patient-Matched Guides for Orthopedic Implants.\" This guidance document provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides for orthopedic implants. This guidance also provides recommendations that manufacturers should consider when developing their design process for these device types. This guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review.","document_number":"2026-09023","html_url":"https://www.federalregister.gov/documents/2026/05/07/2026-09023/patient-matched-guides-for-orthopedic-implants-guidance-for-industry-and-food-and-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-07/pdf/2026-09023.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09023.pdf?1778071520","publication_date":"2026-05-07","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"submit either electronic or written comments on Agency guidances at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal eRulemaking Portal: \n \n https://www.regulations.gov. \n Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to \n https://www.regulations.gov \n will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential"},{"title":"E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"E22 General Considerations for Patient Preference Studies.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). When finalized, this guidance will provide general principles for the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of such approvals.","document_number":"2026-02324","html_url":"https://www.federalregister.gov/documents/2026/02/06/2026-02324/e22-general-considerations-for-patient-preference-studies-international-council-for-harmonisation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-06/pdf/2026-02324.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02324.pdf?1770299111","publication_date":"2026-02-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"comments on any guidance at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal eRulemaking Portal: \n \n https://www.regulations.gov. \n Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to \n https://www.regulations.gov \n will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party"},{"title":"Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures","type":"Rule","abstract":"This final rule implements requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, enacted on March 30, 2010--collectively, the Affordable Care Act. Specifically, this final rule adopts standards for health care claims attachments transactions, which will support health care claims transactions, and a standard for electronic signatures to be used in conjunction with health care claims attachments transactions.","document_number":"2026-05676","html_url":"https://www.federalregister.gov/documents/2026/03/24/2026-05676/administrative-simplification-adoption-of-standards-for-health-care-claims-attachments-transactions","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-24/pdf/2026-05676.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05676.pdf?1774037709","publication_date":"2026-03-24","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"stated that an electronic signature can be any of several types of marks or data that indicate a signatory's intent to sign and included examples of electronic signatures. \n We proposed to define the term “electronic signature” for purposes of the HIPAA Standards for Health Care Attachments proposed rule as broadly as possible to ensure that it would meet covered entities' current needs and could also encompass future electronic signature technologies. The proposed text in § 162.103 read: “Electronic signature means an electronic sound, symbol,"},{"title":"Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled \"Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.\" This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can submit patient experience and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. This guidance finalizes the draft guidance of the same title issued on June 30, 2022.","document_number":"2025-20153","html_url":"https://www.federalregister.gov/documents/2025/11/18/2025-20153/patient-focused-drug-development-selecting-developing-or-modifying-fit-for-purpose-clinical-outcome","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-18/pdf/2025-20153.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20153.pdf?1763387133","publication_date":"2025-11-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can submit patient experience and other relevant information from patients and caregivers to be used for medical product development and regulatory"},{"title":"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers.\" This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled \"Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1)\" issued on May 24, 2022.","document_number":"2025-11928","html_url":"https://www.federalregister.gov/documents/2025/06/27/2025-11928/antibacterial-therapies-for-patients-with-an-unmet-medical-need-for-the-treatment-of-serious","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-27/pdf/2025-11928.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11928.pdf?1750941919","publication_date":"2025-06-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"may submit either electronic or written comments on Agency guidances at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal eRulemaking Portal: https://www.regulations.gov. \n Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to \n https://www.regulations.gov \n will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential"},{"title":"Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled \"Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.\" Patients provide valuable input to FDA in a variety of forms. This guidance describes the principles and concepts that FDA recommends sponsors and other interested parties consider when collecting and submitting patient preference information (PPI), discusses FDA's inclusion of PPI in its decision summaries, and provides recommendations for the inclusion of such information in device labeling for certain devices. PPI can be used in FDA decision making across the total product life cycle, including during review of investigational device exemption (IDE) applications, requests for a Breakthrough Device designation, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, premarket notifications (510(k)s), or for FDA decisions involving administrative, enforcement, or other actions.","document_number":"2026-06063","html_url":"https://www.federalregister.gov/documents/2026/03/30/2026-06063/incorporating-voluntary-patient-preference-information-over-the-total-product-life-cycle-guidance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-30/pdf/2026-06063.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06063.pdf?1774615515","publication_date":"2026-03-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"submit either electronic or written comments on Agency guidances at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal eRulemaking Portal: \n \n https://www.regulations.gov. \n Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to \n https://www.regulations.gov \n will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential"},{"title":"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP).\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes three documents: a guidance, a template, and a technical specification document. The guidance provides the rationale and recommendations for implementing a harmonized digital clinical trial protocol. The template features standardized content structure and formatting, including headers and common text elements. The technical specification document contains harmonized terminologies and standardized data fields to enable electronic exchange of clinical protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of clinical trial protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This guidance finalizes the draft guidances \"M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)\" issued on December 22, 2022 (87 FR 78696), and \"M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol\" issued on June 6, 2025 (90 FR 24146).","document_number":"2026-10295","html_url":"https://www.federalregister.gov/documents/2026/05/22/2026-10295/m11-clinical-electronic-structured-harmonised-protocol-cesharp-international-council-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-22/pdf/2026-10295.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10295.pdf?1779367514","publication_date":"2026-05-22","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"submit either electronic or written comments on Agency guidances at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal eRulemaking Portal: \n \n https://www.regulations.gov. \n Follow the \n \n instructions for submitting comments. Comments submitted electronically, including attachments, to \n https://www.regulations.gov \n will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential"},{"title":"Continuity of Care via Telemedicine for Veterans Affairs Patients","type":"Rule","abstract":"This final rule authorizes Department of Veterans Affairs (VA) practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation. VA practitioners are permitted to prescribe controlled substances to VA patients if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to certain conditions.","document_number":"2025-01044","html_url":"https://www.federalregister.gov/documents/2025/01/17/2025-01044/continuity-of-care-via-telemedicine-for-veterans-affairs-patients","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01044.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-01044.pdf?1736948756","publication_date":"2025-01-17","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"},{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"practitioner must limit the prescription to a 7-day supply and must later review both the VA patient's VA EHR (to include the internal prescription database) and the PDMP data for the state in which the patient is located at the time of the telemedicine encounter for prescriptions of controlled substances issued to the patient before continuing to prescribe controlled substances to the patient via telemedicine. If no PDMP program exists for the state in which the VA patient is located at the time of the telemedicine encounter the practitioner must review"},{"title":"Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017","type":"Rule","abstract":"The \"Protecting Patient Access to Emergency Medications Act of 2017,\" (the Act) which became law on November 17, 2017, amended the Controlled Substances Act (CSA) to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration is publishing this final rule to conform its regulations to the statutory amendments of the CSA and to otherwise implement its requirements. This final rule adopts, with minor modifications, the notice of proposed rulemaking published on October 5, 2020.","document_number":"2026-02288","html_url":"https://www.federalregister.gov/documents/2026/02/05/2026-02288/registering-emergency-medical-services-agencies-under-the-protecting-patient-access-to-emergency","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-05/pdf/2026-02288.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02288.pdf?1770153307","publication_date":"2026-02-05","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"substances. This definition would include instances when an EMS vehicle is responding to an emergency, is transporting patients, or is on call. “On call” means that personnel are ready and available to respond, but may not be responding to an emergency at that precise moment. EMS vehicles and personnel are considered “on call” when they are prepared to respond to emergencies, even if they are not actively engaged in an emergency call. This includes periods when the vehicle is on standby for the next call, which may include waiting in designated standby"},{"title":"Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges","type":"Proposed Rule","abstract":"These proposals are intended to improve the electronic exchange of health care data and streamline processes related to prior authorization by increasing the interoperability of systems used across the health care industry. We are proposing new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), including issuers that offer small group market QHPs on the Federally-facilitated Small Business Health Options Program (FF- SHOP) Exchanges (hereinafter referred to as \"small group market QHP issuers on the FF-SHOPs\") (collectively \"impacted payers\"), to make available electronic prior authorization for drugs. We are also proposing to extend many existing interoperability requirements for the prior authorization of non-drug items and services to include prior authorizations for drugs to further reduce patient and provider burden. We are also proposing to require impacted payers to report their application programming interfaces (API) endpoints and related information for the Patient Access, Provider Directory, Provider Access, Payer-to-Payer, and Prior Authorization APIs to CMS. To help assess the impact of our policies, we are proposing to collect API usage metrics. In addition, we are proposing to apply the existing interoperability requirements to small group market QHP issuers on the FF-SHOPs as impacted payers. To improve impacted payers' ability to exchange health information while continuing CMS's drive toward interoperability, we are proposing to require certain Health Level Seven (HL7[supreg]) Fast Healthcare Interoperability Resources (FHIR[supreg]) implementation guides (IGs) that are currently recommended. In addition, HHS is proposing to adopt the HL7 FHIR base standard and certain associated specifications and IGs as the Health Insurance Portability and Accountability Act of 1996 (hereinafter referred to as \"HIPAA\") (Pub. L. 104-191, enacted Aug. 21, 1996) standards for dental, professional, and institutional \"referral certification and authorization\" transactions and \"eligibility for a health plan\" transactions associated with prior authorization. We are proposing to add a definition for \"failure to report,\" which would allow CMS to impose a civil monetary penalty (CMP) on applicable manufacturers or applicable group purchasing organizations (GPOs) if those entities fail to grant CMS timely access to documents for the purposes of an audit. Finally, ONC is using this rulemaking to propose to adopt updated versions of certain health information technology (health IT) standards and specifications for HHS use, such as CMS's interoperability requirements, to support a more robust health IT infrastructure.","document_number":"2026-07205","html_url":"https://www.federalregister.gov/documents/2026/04/14/2026-07205/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-standards","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-14/pdf/2026-07205.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07205.pdf?1775852111","publication_date":"2026-04-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"of drugs covered by the payer under the patient's health plan through the Patient Access API. We believe that by requiring these IGs, impacted payers would format data available through the Patient Access API in a consistent manner that would allow health app developers to easily access and display patients' health data, thus having those data readily available and easily accessible to patients. Enabling patients to easily access their health information electronically through an API should allow patients to better manage their health care. \n (2)"},{"title":"Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Core Patient-Reported Outcomes in Cancer Clinical Trials.\" This final guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes (herein referred to as core patient-reported outcomes) in cancer clinical trials and related considerations for instrument selection and trial design. This final guidance focuses on patient-reported outcome (PRO) measures and is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.","document_number":"2024-24111","html_url":"https://www.federalregister.gov/documents/2024/10/18/2024-24111/core-patient-reported-outcomes-in-cancer-clinical-trials-guidance-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-18/pdf/2024-24111.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-24111.pdf?1729169138","publication_date":"2024-10-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"may submit either electronic or written comments on Agency guidances at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal eRulemaking Portal: https://www.regulations.gov. \n Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to \n https://www.regulations.gov \n will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential"},{"title":"Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program","type":"Rule","abstract":"This final rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes provisions related to civil money penalties (CMPs) for noncompliant issuers and other responsible entities; standards governing agents, brokers, and web-brokers; the expansion and codification of hardship exemption eligibility; implementation of the State Exchange Improper Payment Measurement (SEIPM); provider access standards and essential community provider standards for QHP certification; QHP certification of non-network plans; a prohibition on issuers from including routine non-pediatric dental services as an Essential Health Benefit (EHB); requirements related to defrayal for the cost of any State-required benefits in addition to the EHB; cost- sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive plan years; QHP issuer quality improvement strategies (QISs); and revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to States. This final rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation.","document_number":"2026-10050","html_url":"https://www.federalregister.gov/documents/2026/05/20/2026-10050/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2027-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-20/pdf/2026-10050.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10050.pdf?1779135308","publication_date":"2026-05-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"finalizing that these actions may include a hand-written or electronic written signature or initials, made directly on the HHS-approved and -created consumer consent form \n \n indicating a person's consent, approval, or agreement; an email from the consumer or consumer's authorized representative; or a recorded verbal conversation.\n \n Additionally, the Electronic Signatures in Global and National Commerce Act, 15 U.S.C. 7001, is the law that gives electronic signatures the same legal effect as paper ones and includes certain consumer-consent and disclosure"},{"title":"Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers","type":"Rule","abstract":"The Food and Drug Administration (FDA, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).","document_number":"2025-11207","html_url":"https://www.federalregister.gov/documents/2025/06/18/2025-11207/medical-devices-exemptions-from-premarket-notification-class-ii-devices-clinical-electronic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11207.pdf?1750164314","publication_date":"2025-06-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"intended to monitor body temperature, thermometer patches affixed to the patient's skin, or thermometers that are swallowed to monitor a patient's body temperature. FDA considers premarket notification requirements for infrared clinical electronic thermometers with telethermographic functions and clinical electronic thermometers with continuous temperature measurement functions to be necessary to provide a reasonable assurance of safety and effectiveness because such thermometers include newer technology that may require additional testing beyond that specified"},{"title":"Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program","type":"Proposed Rule","abstract":"This proposed rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also includes provisions related to civil money penalties (CMPs) for noncompliant issuers and other responsible entities; standards governing agents, brokers, and web-brokers; the expansion and codification of hardship exemption eligibility; implementation of the State Exchange Improper Payment Measurement (SEIPM); provider access standards and essential community provider standards for QHP certification; QHP certification of non-network plans; a prohibition on issuers from including routine non-pediatric dental services as an Essential Health Benefit (EHB); cost-sharing flexibilities for catastrophic and individual market bronze plans; establishment of catastrophic plans with plan terms of up to 10 consecutive years; QHP issuer quality improvement strategies (QISs); revisions affecting which enrollees are included in Federal Basic Health Program (BHP) payment calculations to States; and seeks comment on potential adjustments to other Federal standards, including the Federal medical loss ratio (MLR) standard in the individual market. This proposed rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation.","document_number":"2026-02769","html_url":"https://www.federalregister.gov/documents/2026/02/11/2026-02769/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2027-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-11/pdf/2026-02769.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02769.pdf?1770671709","publication_date":"2026-02-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"This proposed rule also includes amendments to implement certain provisions of the Working Families Tax Cut (WFTC) legislation. \n \n \n DATES: \n To be assured consideration, comments must be received at one of the addresses provided below, by March 13, 2026. \n \n \n ADDRESSES: \n In commenting, please refer to file code CMS-9883-P. \n Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): \n \n 1. \n Electronically. \n You may submit electronic comments on this regulation"},{"title":"Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability","type":"Proposed Rule","abstract":"This proposed rule seeks to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information through proposals for: standards adoption; adoption of certification criteria to advance public health data exchange; expanded uses of certified application programming interfaces, such as for electronic prior authorization, patient access, care management, and care coordination; and information sharing under the information blocking regulations. It proposes to establish a new baseline version of the United States Core Data for Interoperability. The proposed rule would update the ONC Health IT Certification Program to enhance interoperability and optimize certification processes to reduce burden and costs. The proposed rule would also implement certain provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA), which would support the reliability, privacy, security, and trust within TEFCA.","document_number":"2024-14975","html_url":"https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-05/pdf/2024-14975.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14975.pdf?1721825115","publication_date":"2024-08-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"requirements to support patient authorization using SMART App Launch capabilities. Specifically, we clarify that if both the “permission-patient” and “permission-v2” capabilities are required in support of patient authorization for certification to a criterion in the Program, then a Health IT Module must support the following: \n • Support for the ability for patients to authorize an application to receive their EHI based on individual FHIR resource-level and individual sub-resource-level scopes. \n • Support for the ability for patients to authorize an application"},{"title":"Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program","type":"Proposed Rule","abstract":"This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2027. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2027. It also continues the third year of the 3-year phaseout of the rural adjustment, which began in FY 2025. This proposed rule includes a solicitation for public comments on alternative data sources for the IRF PPS wage index; proposes to require all therapy treatments or therapy evaluations to begin within 36-hours from midnight on the day of admission; proposes to require a patient's current functional status be documented on the preadmission screening; proposes requirements for the initial Interdisciplinary Team meeting; and includes a request for information on potential future IRF PPS payment reform. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program. Furthermore, the proposed rule includes changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program.","document_number":"2026-06642","html_url":"https://www.federalregister.gov/documents/2026/04/06/2026-06642/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-06/pdf/2026-06642.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06642.pdf?1775160907","publication_date":"2026-04-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"and includes the patient's medical prognosis, anticipated interventions, functional outcomes, and discharge destination. Per § 412.622(a)(4)(ii), the POC must be developed by a rehabilitation physician and documented in the patient's medical record or electronic health record by day 4 of the patient's admission to the IRF. \n The current IDT meeting policy (42 CFR 412.622(a)(5)) states that IDT meetings must occur “at least once per week throughout the duration of the patient's stay,” with a “week” defined as a period of 7 consecutive calendar days"},{"title":"Electronic Signatures, Forms and Storage for Drug and Alcohol Testing Records","type":"Proposed Rule","abstract":"The Department of Transportation (DOT or Department) proposes to amend its regulations for conducting workplace drug and alcohol testing for the federally regulated transportation industry to allow, but not require, electronic signatures on documents required to be created and utilized under the regulations, the use of electronic versions of forms, and the electronic storage of forms and data. The regulatory changes would apply to DOT-regulated employers and their contractors (\"service agents\") who administer their DOT-regulated drug and alcohol testing programs. Currently, employers and their service agents must use, sign and store paper documents exclusively, unless the employer is utilizing a laboratory's electronic Federal Drug Testing Custody and Control Form (electronic CCF) system that has been approved by the Department of Health and Human Services (HHS). DOT is required by statute to amend its regulations to authorize, to the extent practicable, the use of electronic signatures or digital signatures executed to electronic forms instead of traditional handwritten signatures executed on paper forms. This rulemaking also responds to an April 2, 2020, petition for rulemaking from DISA Global Solutions, Inc. (DISA), requesting that DOT regulations be amended to allow the use of an electronic version of the alcohol testing form (ATF) for DOT-authorized alcohol testing. The proposed regulatory amendments are expected to provide additional flexibility and reduced costs for the industry while maintaining the integrity and confidentiality requirements of the drug and alcohol testing regulations. In addition, DOT proposes to amend the Pipeline and Hazardous Materials Safety Administration (PHMSA) regulation for conformity and to make other miscellaneous technical changes and corrections.","document_number":"2024-23427","html_url":"https://www.federalregister.gov/documents/2024/10/15/2024-23427/electronic-signatures-forms-and-storage-for-drug-and-alcohol-testing-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-15/pdf/2024-23427.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-23427.pdf?1728650733","publication_date":"2024-10-15","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Office of the Secretary"},{"raw_name":"Pipeline and Hazardous Materials Safety Administration","name":"Pipeline and Hazardous Materials Safety Administration","id":408,"url":"https://www.federalregister.gov/agencies/pipeline-and-hazardous-materials-safety-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/408","parent_id":492,"slug":"pipeline-and-hazardous-materials-safety-administration"}],"excerpts":" the use of an electronic version of the DOT ATF that is identical in form and content to the form provided in appendix I to part 40. The electronic ATF must be capable of capturing the electronic signatures of the employee and the BAT and/or STT, and if an EBT provides a separate printout of confirmation test results pursuant to § 40.253(g), the electronic ATF must include that separate printout. This section would also be amended to specify the same general confidentiality and security measures in § 40.45 relating to electronic CCFs to ensure"},{"title":"M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Technical Specification; and Template; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the revised draft technical specification entitled \"M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)\" and a supplemental document entitled \"M11 Template.\" The revised draft technical specification and template were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information. The template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. These ICH documents create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This revised draft technical specification and updated template revise and replace the draft versions of the same titles issued in December 2022.","document_number":"2025-10359","html_url":"https://www.federalregister.gov/documents/2025/06/06/2025-10359/m11-technical-specification-clinical-electronic-structured-harmonised-protocol-international-council","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-06/pdf/2025-10359.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-10359.pdf?1749127521","publication_date":"2025-06-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"DATES: \n Submit either electronic or written comments on the draft guidance by July 7, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. \n \n \n ADDRESSES: \n You may submit comments on any guidance at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal eRulemaking Portal: https://www.regulations.gov \n . Follow the instructions for submitting comments. Comments submitted electronically, including attachments"},{"title":"Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.\" This draft guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit patient preference information (PPI). The knowledge gleaned from the use of PPI could be used across the total product life cycle, including for review in investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, or premarket notifications (510(k)s). This draft guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. This draft guidance is not final nor is it for implementation at this time.","document_number":"2024-20069","html_url":"https://www.federalregister.gov/documents/2024/09/06/2024-20069/incorporating-voluntary-patient-preference-information-over-the-total-product-life-cycle-guidance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-06/pdf/2024-20069.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20069.pdf?1725540334","publication_date":"2024-09-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":" Submit either electronic or written comments on the draft guidance by December 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. \n \n \n ADDRESSES: \n You may submit comments on any guidance at any time as follows: \n \n Electronic Submissions \n Submit electronic comments in the following way: \n \n • \n Federal eRulemaking Portal: \n \n https://www.regulations.gov. \n Follow the instructions for submitting comments. Comments submitted electronically, including attachments"}]}